South Africa has the largest pharmaceutical products market in Africa and the pharmaceutical industry plays an important role in the South African economy. Patentability is the economic driver for research and innovation. Contrary to the fear that patentability may curtail access to medicines by making them more expensive, patentability serves as an economic incentive for the manufacture and distribution of drugs within an economy.
Applicants are often unfamiliar with the position of second medical uses (ie, new uses of known pharmaceutical compounds), method of treatment claims and Swiss-type claims in South Africa due to the significant differences in the applicable legislation compared to that in other jurisdictions such as Europe and the United States.
Method of treatment claims
Method of treatment claims – for example, "a method of treating [condition Y] comprising administering [compound X]" – are not allowable in South Africa.
Second medical use claims
In Europe, under the European Patent Convention (EPC) 2000 claim form, second medical uses – for example, "[Compound X]* for use in the treatment of [condition Y] (*where compound X is a known compound)" – are allowable.
Strictly speaking, South Africa does not permit patents covering new uses of known pharmaceutical compounds (ie, second medical use claims). Following the original European provision, the Patents Act provides that a known substance can be claimed for use in a method of medical treatment only the first time that it is disclosed as being useful in a medical treatment. The South African courts have confirmed this.
Once the use of the compound in a method of medical treatment has formed part of the state of the art, it cannot be claimed a second time in respect of a new medical use.
In order to overcome this prohibition, South Africa has adopted Swiss-type claims to provide protection in instances where a second medical use is sought to be protected. This serves as a mechanism by which second medical uses are protectable in South Africa, albeit through the Swiss form and not via direct protection of the second medical use.
Swiss-type claims take the form of "Use of [compound X] in the manufacture of a medicament for the treatment of [condition Y]".
Swiss-type claims focus on the method of manufacture. Once disclosed, the method forms part of the prior art and thus any subsequent Swiss-type claims that vary the dosage regimes may not be patentable.
However, this aspect of Swiss-type claims has not been tested in the South African courts. It may be that a Swiss-type claim characterised by a certain dosage regime may be considered to be patentable.
The position of different claim formulations in South Africa may be summarised as follows:
- Method of treatment claims are not patentable in South Africa;
- Second medical use claims are not patentable in South Africa; and
- Swiss-type claims are patentable in South Africa.
South Africa is considering implementing a substantive patent examination system (at present, a depository system is in place) and pre and post-grant opposition procedures as a means of preventing patent evergreening.
The government's policy also suggests that the existing systems for patents and the registration of medicines should be aligned. Alignment would prevent patents being granted to medicines that may be about to expire, and thereby prevent the undermining of access to public health. The policy also specifically states that South African legislation must impose strict rules and should exclude new uses of known products.
In an effort to promote access, including access to medicines at lower prices, South Africa is currently considering using the mechanism of compulsory licensing to urge patent holders to license manufacturing rights to third parties, thus enabling a reduction in price.
Although compulsory licensing has no direct impact on the allowability of second medical use claims, it would have a substantial effect on the South African position on access to medicines and the tendency to move towards a patent system that does not favour second medical use claims.
Regarding generic medication, the Bolar provision applies in South Africa. This provision allows generic companies to complete the requisite regulatory approval process before expiry of the patent so that on expiry, they are entitled to enter into the market. However, the law does not allow for stockpiling.
Swiss-type claims are allowable in South Africa, and thus the pharmaceutical industry may still obtain protection in respect of second medical uses using this type of claim format. It is not recommended to include method of treatment claims or EPC 2000 claim forms, as these are not permitted in South Africa.
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